Improving Adherence to COPD Treatments in Primary Care

NCT07104136 | Enrolling By Invitation

• 1 other identifier: 0195-24-COM1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a special training program for primary care doctors can help improve treatment adherence and overall outcomes for people with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are:

• Does the training program help patients with COPD take their medications more regularly?
• Does it reduce the number of COPD flare-ups (exacerbations)?
• Does it improve how well doctors follow current treatment guidelines for COPD? In this study:
• Primary care doctors will be randomly assigned to either receive the training or continue their usual care without intervention.
• The training includes updated information about COPD, a workshop on inhaler use, and a course on motivational interviewing (a method to support behavior change)
• The care of their patients with COPD will be reviewed over 12 months to see if the program made a difference in medication use, flare-ups, and other outcomes.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Adherence to Care

Keywords

COPD; Primary care; Motivational interviewing; Inhalers

Outcome Measures

Primary Outcomes (1)

• Adherence to COPD-related inhalers

  Change in inhaler adherence from first clinic visit after trial initiation. Measured by the purchase of prescribed COPD inhalers and compared with the control group. The primary outcome will be assessed using the Proportion of Days Covered (PDC) method, calculated as the percentage of days a patient has medication available over the observation period. This outcome will be comapred between the intervention and control groups

  From first patient visit after study initiation to 12 months after.

Secondary Outcomes (8)

• Change in adherence to inhaler therapy pre-post study

  From first patient visit after study initiation to 12 months after.

• Non-inhaler medications adherence pre-post study

  From first patient visit after study initiation to 12 months after.

• Non-inhaler medication adherence

  From first patient visit after study initiation to 12 months after.

• Annualized rate of moderate or severe COPD exacerbations

  From first patient visit after study initiation to 12 months after.

• All-cause mortality

  From first patient visit after study initiation to 12 months after.

Other Outcomes (6)

• New diagnoses of cardiovascular diseases - post hoc analysis

  From first patient visit after study initiation to 12 months after.

• Rate of guidelines-based cardiovascular treatment - post-hoc analysis

  From first patient visit after study initiation to 12 months after.

• Cardiovascular events - post-hoc analysis

  From first patient visit after study initiation to 12 months after.

Study Arms (2)

Intervention

EXPERIMENTAL

In the study, primary care physicians assigned to the intervention group will participate in a two-day seminar led by senior pulmonology specialists and family medicine specialists. The seminar will cover the following topic: Understanding COPD and current guidelines, inhaler technique and device selection, cardiovascular diseases in patients with COPD and possible interventions, motivational interview seminar, and two workshops for simulation and practice. The physicians will undergo a refresher workshop 3 months after entering the study, and visual and informative newsletter will be sent to them every 3 months.

Behavioral: COPD-care seminar

Control

NO INTERVENTION

Primary care physicians that will be included without any intervention.

Interventions

COPD-care seminar BEHAVIORAL

A two day seminar which will include: Lectures: Understanding COPD and Current Guidelines COPD pathophysiology. Review of the latest GOLD guidelines and treatment strategies Hands-on Session: Inhaler Technique and Device Selection Practical demonstration of different inhaler devices. Evaluating patient inspiratory effort and selecting suitable devices. Understanding advantages of each device and molecule. Cardiovascular diseases in COPD - real-world evidence, how to identify at-risk patients, and intervention. Motivational interview seminar- On line pre-course lectures about the theory behind motivational interview. Two workshops for simulation and practice of the technic through clinical cases with relevance to COPD patients including smoking cessation counseling techniques. Panel Discussion: Multidisciplinary Approach to COPD Management Involving respiratory specialists, physiotherapists, and primary care physicians. Discussion on referral practices and collaborative care.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care physicians
• Have at least 18 COPD patients in his unit as documented in medical records

You may not qualify if:

• Refusal to sign informed consent to participate in the study.
• Less than 1-year projection of employment in current clinic.
• Prior completion of a course in motivational interviewing.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Clalit Health Services: collaborator

Study Sites (1)

Clalit health services

Tel Aviv, Israel

Location

Related Publications (1)

• Martinez FJ, Thomashow B, Sapir T, Simone L, Carter J, Han M. Does Evaluation and Management of COPD Follow Therapeutic Strategy Recommendations? Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):230-242. doi: 10.15326/jcopdf.2020.0175.

  PMID: 33610138 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients that will have their outcomes annalyzed will be unaware of group allocation or of the study considering data will be annalyzed retrospectively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 5, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)